NEW: BNAC and Zivadinov Review in Neurotherapeutics

A forum to discuss Chronic Cerebrospinal Venous Insufficiency and its relationship to Multiple Sclerosis.

Postby cheerleader » Fri Aug 26, 2011 9:12 am

BNAC is still looking for people to participate in their PREMISe trial:

PROSPECTIVE RANDOMIZED ENDOVASCULAR THERAPY IN MULTIPLE SCLEROSIS (PREMiSe)
We are seeking participants for currently ongoing Prospective Randomized Endovascular Therapy in multiple sclerosis (PREMiSe) trial being conducted by the Departments of Neurology and Neurosurgery to evaluate the effectiveness of intravascular angioplasty for the treatment of venous narrowing in the treatment of MS.

Study volunteers will undergo catheter venography followed by a balloon angioplasty procedure. Study testing will include Doppler ultrasound, MRI with MRV, physical and neurological examinations, CT Angiogram (CTA) of the head and neck and CT Perfusion (CTP) of the head. All of these tests will be performed at baseline (prior to any treatment) and at 1 month after treatment. A subset of these tests will also be performed 3, 6 and 12 months post-treatment.

One important aspect of the study is that only 50% of the participants in this study will receive an interventional treatment using balloon angioplasty. The other 50% of participants will have the same procedure but without insertion of any balloons. Participants would not be told if they had the treatment that is being tested or, if they had what is known as a “sham” procedure. It is an important requirement of this study that prospective participants understand that it will not be disclosed if they did or did not receive treatment for CCSVI until 6 months after the close of enrollment and randomization.

1) Applications will be processed according to our study criteria and in the order they are received.

2) Once the team evaluates the information you provide in the questionnaire, you will be contacted to inform you if you are eligible for further screening.

You must be:
Adult MS must be supported by fulfillment of the McDonald criteria
Meet criteria for the presence of Chronic Cerebrospinal Venous Insufficiency (CCSVI)
Be on treatment with currently FDA approved disease-modifying treatments (excluding Tysabri)
Have an EDSS score of 0-5.5
Have normal kidney functioning as supported by lab work performed within 2 months of MRI testing (within 2 weeks if other criteria are met)
Be able to communicate effectively
Pass screening for MRI and contrast agent safety
Be able to travel to Buffalo, NY to complete testing (we only have this site for testing)
You must not:
Be in active relapse or have steroid treatment in 30 days prior to MRI
Have any vascular or heart problems
Have severe cognitive impairment/dysfunction
Have a history of drug or alcohol abuse, cerebrovascular disease or cerebral vascular malformations, head injury or brain trauma
Have any vascular malformations (Bechet Disease, Budd Chiari Syndrome, Congenital vascular malformations, Deep Vein Thrombosis within the past year, Chronic Venous Insufficiency of the lower limbs)
Have an allergy to contrast
Be unwilling to undergo the endovascular treatment
Be pregnant or expect to be pregnant during participation
You can provide your contact information for immediate screening by completing a form athttp://vovici.com/wsb.dll/s/8727g4c369.

Please do not make any travel plans until your enrollment is confirmed. All testing procedures are paid for by the study research grants. However, there is no financial compensation for your participation, or travel and related expenses.

We kindly ask completion of only one contact information form per patient.


cheer
Husband dx RRMS 3/07
dx dual jugular vein stenosis (CCSVI) 4/09
http://ccsviinms.blogspot.com
User avatar
cheerleader
Family Elder
 
Posts: 5019
Joined: Mon Sep 10, 2007 3:00 pm
Location: southern California

Postby MrSuccess » Fri Aug 26, 2011 1:43 pm

let's hope people step up on this and take part ...... it's going to be a freebie CCSVI treatment ...... isn't that the stumbling point ... the cost ?

For the Record :

Mr.Success has no doubt whatsoever that CCSVI and MS are connected.

Mr.Success supports and looks to Dr.Zamboni ...... as the medical professional to look to and listen to ......in all things CCSVI.

Mr.Success has never for one second ...... not supported and trusted the BNAC and Dr.s Zivadov and Bianca- Weinstock .

Mr.Success is fascinated by the work and CCSVI revelations of Dr.Sclafani.

Mr. Success wishs Dr. Hubbard would be the offical spokesperson for all things CCSVI. No disrespect intended towards the other magnificent pioneer CCSVI medical professionals .

Now ..... here is my concern.

I have not heard-read of any CCSVI trial or investigation ..... that featured any test subjects being treated ..... that were NOT taking some
form of Disease Modifying Drug. [ DMD ]

Until there is a CCSVI Trial - including treatment - that is done on pwMS and CCSVI .... that DO NOT and HAVE NEVER .... used ANY ...DMD's .....
the doubting Neuro's and BIG Pharm ....... will always claim any improvements are as a result of their product.

There is only one way to prove them wrong ....... and that the Liberation procedure is beneficial.......... test and treat those people I mentioned. :idea:


Mr.Success
User avatar
MrSuccess
Family Elder
 
Posts: 886
Joined: Fri Sep 18, 2009 3:00 pm

Postby 1eye » Fri Aug 26, 2011 3:46 pm

EDSS 0-5.5. Guess I'm off the hook. Anybody doing anything for us SPMS's?
"Try - Just A Little Bit Harder" - Janis Joplin
CCSVI procedure Albany Aug 2010
'MS' is over - if you want it
Patients sans/without patience
User avatar
1eye
Family Elder
 
Posts: 2885
Joined: Wed Mar 17, 2010 4:00 pm
Location: Kanata, Ontario, Canada

Postby 1eye » Sun Aug 28, 2011 9:43 am

recent Buffalo study wrote:
If such trials establish an initial benefit for endovascular therapy, then properly powered Phase III clinical trials should be conducted to prove whether this type of treatment can be made widely available. However, in our opinion, until these steps are accomplished, there is no role for the endovascular treatment of CCSVI in MS patients outside of approved clinical trials.


Good thing private individuals don't have to go along with opinions.
"Try - Just A Little Bit Harder" - Janis Joplin
CCSVI procedure Albany Aug 2010
'MS' is over - if you want it
Patients sans/without patience
User avatar
1eye
Family Elder
 
Posts: 2885
Joined: Wed Mar 17, 2010 4:00 pm
Location: Kanata, Ontario, Canada

Re: NEW: BNAC and Zivadinov Review in Neurotherapeutics

Postby Cece » Wed Oct 19, 2011 9:24 am

http://www.medscape.com/viewarticle/751767
Some comments from Dr. Zivadinov on this article
In general, however, he agreed that the literature to date has been less than reliable, with many small observational studies, varied methodology, and what appears to be a bias for studies showing no relationship between CCSVI and MS being published in neurological journals, and those finding positive relationships being published in radiological journals.
One of the issues requiring definition is the various venous abnormalities themselves, not just the blockage of venous outflow but also the precise abnormalities that are causing any blockage, he noted. Multimodal studies that use more than 1 imaging technique to examine these abnormalities appear to be more reliable. Intravenous Doppler, for example, is perhaps the most reliable of these modalities, Dr. Zivadinov noted, allowing direct visualization of the abnormalities in the pulsatile venous setting.
"I really think that one of the key messages of this review paper is that we are making clear the importance of a multimodal approach, of standardized guidelines, and of understanding what you are looking at," Dr. Zivadinov concluded. "While there is a common knowledge among radiologists about how to perform diagnostic imaging and intervention on the extracranial vessels, there are no guidelines for CCSVI, and before people begin to do research studies and say it's something or it's not, they should understand the arguments and understand how to do it, and follow some guidelines."

The authors are critical, however, of the so-called Zamboni criteria that outline 5 abnormalities, the presence of 2 or more of which constitute CCSVI. "I think the binary composite of these criteria is probably the major confusion at the moment in the literature," he said. "Basically, if you don't find that second criteria, you are classifying all of your subjects as negative, although the patient or subject may have important venous abnormalities."
Cece
Family Elder
 
Posts: 8994
Joined: Mon Jan 04, 2010 4:00 pm

Re: NEW: BNAC and Zivadinov Review in Neurotherapeutics

Postby 1eye » Wed Oct 19, 2011 12:55 pm

OK, why don't they rerun the trial with IVUS? I think it may end up being what differentiates a diagnostic invasive procedure from a treatment. That, and MRV. You could spend a lot of money without blowing up any balloons. Once people have seen the irrefutable photographic evidence that a major problem needs to be treated in a large number of people, maybe some development dollars will go into treatments with more of a success rate.

We need to admit to ourselves: congenital malformation is a random thing, and so there is no solution for the outliers. Plus what's good for you may harm me.

Since we're on the subject, a couple of places boast the "full Haacke" protocol. Is it useful, or just information we can't use yet? If I went to Brooklyn (can't afford California, and they don't all use IVUS), would some 3d images come in handy?
"Try - Just A Little Bit Harder" - Janis Joplin
CCSVI procedure Albany Aug 2010
'MS' is over - if you want it
Patients sans/without patience
User avatar
1eye
Family Elder
 
Posts: 2885
Joined: Wed Mar 17, 2010 4:00 pm
Location: Kanata, Ontario, Canada

Re: NEW: BNAC and Zivadinov Review in Neurotherapeutics

Postby Cece » Wed Oct 19, 2011 3:01 pm

1eye wrote:Since we're on the subject, a couple of places boast the "full Haacke" protocol. Is it useful, or just information we can't use yet? If I went to Brooklyn (can't afford California, and they don't all use IVUS), would some 3d images come in handy?

I had a haacke protocol MRV done, and it was not of use when it came time to get the procedure done....

The MRV is useful for research but it seems not right for patients to pay out-of-pocket for such an expensive diagnostic tool that has been shown in Dr. Zivadinov's research to be less acccurate than the much cheaper doppler ultrasound at diagnosing CCSVI.

Once the procedure begins, the flouroscopy images are better than anything shown in the MRV. And since you've already had the procedure, you should already have some good pics. One thing that shows on the MRV is the dural sinuses, so if you went to a doctor who did not interrogate the dural sinuses, you might miss out on that. But in Brooklyn, he checks the dural sinuses.
Cece
Family Elder
 
Posts: 8994
Joined: Mon Jan 04, 2010 4:00 pm

Re: NEW: BNAC and Zivadinov Review in Neurotherapeutics

Postby 1eye » Wed Oct 19, 2011 3:58 pm

I just finished watching Dr. Haacke's talk from July on YouTube. He spent a couple of slides explaining that MR images can tell you if the person does or does not have normal flow. He described a patient who was treated, and the images showed normal flow before the treatment. The patient now is occluded I think in both IJVs. I would think if he planned the treatment based on a good image of the veins, and images and graphic evidence of the actual flow patterns (Dr. Haacke called it 4d imaging, because of the time component), the result might stand up better.

I would feel more confident if the doctor had as much info beforehand as possible. The 4d MRV is a very valuable tool. Dr. Haacke's work proves a lot about CCSVI. I can't think if you had those pictures you would even need a Doppler, which has not proven itself everywhere. 4d MRV is not less valuable than Doppler. You can see reflux happen just as easily, and you might only have to spend 20 minutes being scanned. Yours may not have helped you, but others might have been better off if they'd had it, and a doctor who knew what to look for. I think these videos should be required viewing. No angioplasty without seeing them. I understand it is very technical. A lot of people won't understand it, but most doctors should.

Dr. Beggs is quite revealing, too.
"Try - Just A Little Bit Harder" - Janis Joplin
CCSVI procedure Albany Aug 2010
'MS' is over - if you want it
Patients sans/without patience
User avatar
1eye
Family Elder
 
Posts: 2885
Joined: Wed Mar 17, 2010 4:00 pm
Location: Kanata, Ontario, Canada

Previous

Return to Chronic Cerebrospinal Venous Insufficiency (CCSVI)

 


  • Related topics
    Replies
    Views
    Last post

Who is online

Users browsing this forum: No registered users


Contact us | Terms of Service